Biotechnology Regulatory Affairs Specialist

At BioFuture Labs, we are committed to creating a diverse and inclusive work environment. We value our employees and offer competitive compensation and benefits packages, including medical, dental, and vision insurance, 401(k) matching, and more. We also provide opportunities for career growth and development, as well as a collaborative and supportive work culture. If you are passionate about biotechnology and regulatory affairs and want to make a positive impact on the world, we encourage you to apply for the Biotechnology Regulatory Affairs Specialist position at BioFuture Labs.

Job Title: Biotechnology Regulatory Affairs Specialist

Location: Antalya, Turkiye

Employment Type: Full-time

About the Company: BioFuture Labs is a leading biotechnology company that focuses on developing innovative solutions for various healthcare needs. With cutting-edge technology and a team of highly skilled professionals, we strive to make a positive impact on the lives of people around the world. As we continue to grow, we are seeking a highly motivated and experienced Biotechnology Regulatory Affairs Specialist to join our team.

Job Summary: As a Biotechnology Regulatory Affairs Specialist, you will be responsible for ensuring that our company's products comply with all applicable regulations and guidelines. You will work closely with regulatory agencies, internal teams, and external partners to ensure that our products meet all necessary requirements for market approval. This is a critical role that requires strong attention to detail, excellent communication skills, and a deep understanding of biotechnology and regulatory processes.

Key Responsibilities:

• Monitor and analyze changes in regulations and guidelines related to biotechnology products, and communicate any potential impact to the company.
• Prepare and submit regulatory submissions, including but not limited to INDs, NDAs, BLAs, and other relevant documents.
• Collaborate with cross-functional teams to develop and execute regulatory strategies for new and existing products.
• Review and approve product labeling, promotional materials, and other documents to ensure compliance with regulatory requirements.
• Communicate with regulatory agencies, including the FDA, EMA, and other global agencies, to ensure timely and accurate submission of regulatory documents and responses to queries.
• Maintain up-to-date knowledge of global regulatory requirements, and ensure that all products meet these requirements.
• Develop and maintain regulatory policies and procedures to ensure compliance with all applicable regulations and guidelines.
• Participate in internal and external audits, and provide support for regulatory inspections.
• Provide guidance and training to other team members on regulatory requirements, as needed.

Qualifications:

• Bachelor's degree in a scientific or healthcare-related field. Advanced degree preferred.
• Minimum of 3-5 years of experience in biotechnology regulatory affairs.
• Strong understanding of global regulatory processes and requirements for biotechnology products.
• Experience with regulatory submissions, including INDs, NDAs, BLAs, and other relevant documents.
• Excellent communication skills, with the ability to effectively communicate with both internal and external stakeholders.
• Strong attention to detail and ability to manage multiple projects simultaneously.
• Proven track record of successful interactions with regulatory agencies.
• Ability to work independently and in a team environment.
• Proficient in Microsoft Office and other relevant software.

Join Our Team: We look forward to hearing from you!.